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Institutional Review Board

Glossary

Institutional Review Board Terms as Defined by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services.

Adverse event ‐ an anticipated event whose nature, severity, or frequency is (a) not consistent with the known or foreseeable risk of adverse events associated with the research procedures described in the proposal and informed consent and also not consistent with the characteristics of the subject population being studied, or (b) a protocol deviation, such as the willful neglect of procedures described in the proposal.

Harm ‐ an event or undesirable and unintended, although not necessarily unexpected, effect of the research occurring in human subjects as a result of (a) the interventions and interactions used in the research; or (b) the collection of identifiable private information under the research; or © the undesired changes in thought processes and emotion.

Human subject ‐ a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual; or 2) identifiable private information.

Minimal risk ‐ the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Research ‐ a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Unexpected event ‐ Problems, events, or new information that are unexpected and indicate that research participants or others are at greater risk of harm. Examples of unexpected events include an unintentional breach of confidentiality, publication, or inadvertent emotional distress resulting from behavioral or social survey.

Vulnerable populations ‐ individuals who lack the capacity to provide informed consent or whose willingness to participate in research may be unduly influenced by others. Populations that are potentially vulnerable include: pregnant women; human fetuses and neonates; prisoners; children; persons at risk for suicide; and persons with impaired decisional capability.

EMU Institutional Review Board Policy Terms

Classroom research proposals ‐ Research projects are considered classroom research if they 1) involve human participants for instructional purposes only, 2) involve no more than minimal risk to participants, and 3) do not involve vulnerable populations. If a student plans to publish or present research findings outside the realm of the actual classroom (including thesis publication), the project is not considered classroom research.

Expedited review ‐ Research projects that involve no more than minimal risk and do not involve vulnerable populations to the participants but are presented beyond the realm of the actual classroom including thesis publication are eligible for expedited review.

Full board review ‐ Research projects involving more than minimal risk to participants and involve vulnerable populations require full board review.